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Description of key information

No skin reactions were observed in an OECD 404 study performed in Vienna White rabbits.

During an eye irritation test according to OECD 405, Vienna White rabbits only showed slight redness of the conjuntivae which was reversible in all animals within 7 days.

The substance was not irritating in both in vivo tests.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Conelli S.n.c., Arona (Italy)
- Age at study initiation:about 2-3 months old
- Weight at study initiation: 2-3 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): automatic watering valve system

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C ± 2
- Humidity (%): 55 % ± 10
- Air changes (per hr): 10-20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 g (6 cm²)

Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
Immediately and 72 hours after the 3-minute and the 1-hour exposure period in the first rabbit and at 1,24,48 and 72 hours after the 4-hours exposure period (all rabbits).
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4

Table 1: Dermal erythema reactions after four hours of exposure.

Exp. Period 4 h Erythema and Eschar

Animal #

Obs. Made at

56M

58M

59M

60 minutes

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

  

Table 2: Dermal edema reactions after four hours of exposure. 

Exp. Period 4 h Edema

Animal #

Obs. Made at

56M

58M

59M

60 minutes

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
Neither mortality nor adverse general clinical modifications were seen during the study.
The test substance administered to rabbits by the dermal route, is to be considered "NON IRRITANT" for the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conelli S.n. c. Arona (Italy)
- Age at study initiation: about 2-3 months old
- Weight at study initiation: about 2-3 kg
- Diet: ad libitum
- Water: automatic watering valve system

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2
- Humidity (%): 55 % ± 10
- Air changes (per hr): 15-20 air changes
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect

Table 1: Eye reaction redness observed during the study.

Conjunctivae: Redness

Animal #

Obs. Made at

56M

58M

59M

60 minutes

2

2

2

24 hours

2

2

2

48 hours

1

2

2

72 hours

0

1

1

7 days

0

0

0

 

Table 2: Eye swelling reactions observed during the study.

Conjunctivae:

Chemosis

Animal #

Obs. Made at

56M

58M

59M

60 minutes

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

7 days

0

0

0

 

Table 3: Opacity reactions observed during the course of the study.

Cornea: Opacity

Animal #

Obs. Made at

56M

58M

59M

60 minutes

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

7 days

0

0

0

 

Table 4: Effects on the iris observed during the course of the study.

Iris: Iritis

Animal #

Obs. Made at

56M

58M

59M

60 minutes

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

7 days

0

0

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance administered to rabbits as a single ocular application, is to be considered "NON IRRITANT" for the eye.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN IRRITATION / CORROSION

In the key GLP study, which was done according to the OECD guideline 404, rabbits were occlusively exposed to sebacic acid for 4 h. No mortality or adverse general clinical modifications were seen during the observation period of 72 h and the erythema and edema scores (24/48/72 h) were zero. In a supporting study (Gibraltar Biol. Lab. Rep., 1985) rabbits were occlusively exposed to sebacic acid and the erythema and edema scores (24/48/72 h) were also zero. An additional supporting study (AMRL, 1976) showed also no irritation after occlusive exposure of rabbits to sebacic acid for up to 20 h.

Therefore, sebacic acid is considered to be non-irritant for the skin.

EYE IRRITATION

In the key GLP study rabbits were exposed to sebacic acid for 24 h. Conjunctival redness was observed in all three animals resulting in a mean conjunctivae score (24/48/72 h) of 1.44. The effect was reversible within 7 days. All other scores (cornea, iris and chemosis scores) were zero. The substance was regarded as a non-irritant. In a supporting study (Gibraltar Biol. Lab. Rep., 1985) similar results were observed with the cornea and iris scores = 0 and conjuctival and chemosis scores below 1; all scores: mean over 6 animals and 24/48/72 h. The observed effects were reversible within 48 h.

Therefore, sebacic acid is considered to be non-irritant for the eyes.

RESPIRATORY IRRITATION

There is no information available concerning respiratory irritation.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2018/1480. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008.